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FDA proposes limit for arsenic in apple juice

Drink said to be safe to drink, but 'action level' makes enforcement easier

Almost two years after consumer groups raised alarms over arsenic levels found in apple juice, the Food and Drug Administration on Friday proposed setting an “action level” of 10 parts per billion of inorganic arsenic.
(Heather Charles, Chicago Tribune)

Almost two years after consumer groups raised alarms over arsenic levels found in apple juice, the Food and Drug Administration on Friday proposed an "action level" of 10 parts per billion of inorganic arsenic, the same limit that environmental regulators place on drinking water.

The agency said it was confident that apple juice is generally safe for children and adults to drink but the new limit will make it easier to take enforcement action when higher levels of arsenic are discovered.

"FDA's action level sends a strong signal to industry to help keep out of the food supply even the occasional lot of apple juice with arsenic levels above those permitted in drinking water," FDA spokeswoman Theresa Eisenman said in an email. "The action level will also provide FDA investigators with the information they need when considering regulatory action."

Of 94 samples of apple juice the FDA tested in late 2011, none were found to exceed 10 ppb of inorganic arsenic, a known carcinogen, the agency said. But FDA officials acknowledged that testing from previous years found samples that did exceed 10 parts per billion of inorganic arsenic.

In 2008 the FDA established a "level of concern" for inorganic arsenic in apple juice at 23 ppb. Like an action level, a level of concern can trigger regulatory responses if exceeded, such as ordering further testing or detaining products.

But both levels are seen as less stringent than a formal standard, or tolerance level, which if violated can trigger immediate legal action.

Michael Taylor, the FDA's deputy commissioner for foods and veterinary medicine, said developing tolerance levels involves "an extraordinarily long and cumbersome rule-making process," while action levels can be created less formally and changed to adapt to new evidence.

Urvashi Rangan, director of consumer safety and sustainability for Consumers Union, called the FDA's announcement a move in the right direction. The group serves as the advocacy arm of Consumer Reports, which released the results of its own arsenic testing on apple juice in 2011.

"While we would have liked to see a stronger (rule), we still applaud the FDA for what they did today," Rangan said. "I still think it's a really important first step and good precedent to set an action level for this particular contaminant in food."

The sustainability and food safety group Food & Water Watch was also cautiously hopeful about the move.

"We hope that, at some point, they do put in place some concrete standards, but this is something where the agency can at least work with the industry when these levels are reached or exceeded," said Tony Corbo, a lobbyist for the group.

Inorganic arsenic in food can come from pesticides or from soil and groundwater pollution, though some occurs naturally in the environment. Organic arsenic is viewed as relatively safe, but emerging research suggests that two types of organic arsenic may be toxic. The FDA says these occur rarely or in negligible quantities in apple juice.

The outcry about arsenic and apple juice was triggered by test results that consumer groups and federal officials released in 2011. In FDA testing, 6 percent of 160 samples of apple juice analyzed from 2005 to 2011 exceeded 23 ppb for total arsenic, including both organic and inorganic. At the time the FDA said it was not sure what portion of that total was carcinogenic inorganic arsenic.

Consumers Union had pushed for a limit of 3 ppb of total arsenic in apple juice, saying this level of risk would accept one excess cancer in 1,000 assuming lifelong consumption of apple juice.

According to the FDA's website, more than two-thirds of the 94 samples tested in late 2011 contained levels of inorganic arsenic above 3 ppb. For total arsenic, more than 80 percent exceeded 3 ppb.

Consumer Reports' testing also found that some grape juice samples had higher concentrations of arsenic than apple juice. The FDA's Taylor said the agency is aware of those results but views arsenic and rice as its next most pressing issue.

Last year, Consumer Reports and the FDA reported that some rice products carry high levels of inorganic arsenic residue. The FDA promised to finish 1,000 tests by the end of 2012, but Taylor said those results are still undergoing "quality checks."

"It's turned out to take longer than we expected," he said. "The rice is a lot more complicated than the apple juice because there is such a wide array of rice products … and we want to make sure we do the proper quality checks. I don't want to put out a timetable, but we are working on it and I want people to know that it's on the front burner."

The proposed action level on arsenic in apple juice is subject to 60 days of public comment.